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The ViSI Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and basic arthythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments.

Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients.

The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The Visl Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.

The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, continuous physiological monitoring device intended for the monitoring of ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (SKIN TEMP), posture tracking and alarms, basic arrhythmia analysis (ventricular fibrillation, ventricular tachycardia, asystole, atrial fibrillation) and alarms.

The ViSi Mobile Monitoring System consists of the patient worn devices, disposables, backup battery, patient data server and remote viewer.

This document (K180472) is a 510(k) premarket notification for the ViSi Mobile Monitoring System. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, primarily by highlighting changes and comparing technical characteristics and performance, especially concerning arrhythmia detection.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the traditional sense for the acceptance of the device as a whole. Instead, it presents performance metrics against recognized standards (ANSI/AAMI EC57: 2012) for its arrhythmia detection algorithm, comparing the improved "Proposed Device" (Subject Device) with a "Reference Device A" (K142827), which is a previously cleared version of the ViSi Mobile Monitoring System.

Here's a table derived from the provided "C. Atrial Fibrillation Comparison" and "E. ALARM TEST COMPARISON" sections, focusing on the arrhythmia detection performance:

The study that proves the device meets the acceptance criteria is primarily non-clinical, using established databases.

2. Sample size used for the test set and the data provenance

The test set utilizes publicly available, established databases:

• AHA (American Heart Association)
• MIT-BIH (Massachusetts Institute of Technology - Beth Israel Hospital Arrhythmia Database)
• CU (Creighton University Ventricular Tachyarrhythmia Database)
• NST

The specific sample sizes (e.g., number of ECG recordings or patients) from these databases are not explicitly stated in the provided text. The provenance is from these known databases, which are widely accepted for arrhythmia algorithm testing. The data within these databases is retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states: "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012."

The ground truth for these databases (AHA, MIT-BIH, CU, NST) was established by experts, typically cardiologists or electrophysiologists, during the creation of the databases. The specific number and qualifications of these experts are not detailed within this 510(k) document but are inherent to the accepted nature of these standard databases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set data itself. The ground truth for the test sets (AHA, MIT-BIH, CU, NST databases) was established independently by the creators of those databases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers is not described in this document. The study focuses purely on the algorithm's performance against established gold-standard databases, comparing an updated algorithm to a previous version and recognized standards. The device is not presented as an AI-assistance tool for human readers but rather as a standalone monitoring system with an integrated arrhythmia detection algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes. The performance evaluation presented is a standalone (algorithm only) performance assessment. The tables show the algorithm's sensitivity and positive predictivity for various arrhythmia events (VF/VT, AFIB) when processing the specified ECG databases. The context further reinforces this, stating "Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention," indicating it acts as an aid rather than requiring human modification of its output for the test.

7. The type of ground truth used

The ground truth used for the performance testing is expert consensus from established, recognized ECG databases (AHA, MIT-BIH, CU, NST). These databases contain expert-annotated ECG waveforms, which serve as the gold standard for evaluating arrhythmia detection algorithms.

8. The sample size for the training set

The document does not explicitly state the sample size of the training set used to develop or refine the arrhythmia detection algorithm. It mentions that "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282)," which implies that the training might have occurred prior to this submission (or the core technology was pre-trained).

9. How the ground truth for the training set was established

The document does not explicitly detail how the ground truth for the training set was established. Given that the algorithm is based on (or an adaptation of) the Monebo Technologies, Inc Arrhythmia library, it's highly probable that the training also utilized similar expert-annotated ECG datasets or proprietary clinical data. The document does state that the arrhythmia algorithm was "Rewritten to improve specificity and detection metrics" and later "New arrhythmia detection algorithm to improve arrhythmia detection accuracy and positive predictivity," implying development and testing that would have involved ground truth data.

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The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

The provided text describes a 510(k) premarket notification for the ViSi Mobile Monitoring System with the addition of the ViSi Mobile InSight secondary notification system. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML algorithm's performance on a test set.

Specifically, there is no information in the provided text regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes used for a test set for an AI/ML algorithm, or data provenance.
• Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study details (effect size, human reader improvement with AI).
• Standalone (algorithm only) performance of an AI/ML system.
• Type of ground truth used for an AI/ML system (pathology, outcomes data, etc.).
• Sample size for the training set of an AI/ML algorithm.
• How ground truth for the training set was established for an AI/ML algorithm.

The document discusses performance testing for the ViSi Mobile InSight system, which appears to be a notification and alarm management system, not an AI/ML diagnostic or predictive algorithm. The "Performance Testing" section on page 5 details:

• Human Factors testing: Assessed usability and readability with clinicians familiar with the ViSi Mobile System (not InSight). Used simulated alarms, no patients. Results satisfied defined acceptance criteria.
• Verification activities: Code reviews and unit testing of software components.
• Validation testing: Ensured all software requirements were met. All test steps passed.
• Performance testing in a hospital environment: Characterized alarm receipt and latency under full load (64 transceivers).

This testing is focused on the functionality and usability of the alarm notification system, rather than the diagnostic or predictive performance of an AI/ML model. Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study data from this document.

Ask a specific question about this device

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate, noninvasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.

The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediativ patients or neonates.

The arrhythmia analysis feature is intended for use by healthcation and treatification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinician review of the analysis should precede any therapeutic intervention.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, basic arrhythmias [including ventricular tachycardia, ventricular fibrillation, asystole, and atrial fibrillation/atrial flutter], heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, Sp02, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

The ViSi Mobile Monitoring System for basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation/Atrial Flutter) includes the following acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies that the basic arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which was adapted for real-time analysis. It also states the device has been validated by comparison to specific databases as prescribed by ANSI/AAMI EC57: 2012.

2. Sample Size Used for the Test Set and Data Provenance

The test set included data from the following databases:

• AHA (American Heart Association)
• MIT-BIH Arrhythmia Database
• CU (Creighton University Arrhythmia Database)
• NST (Northrop-Swales Transient Database)

The document does not detail the specific sample size (number of recordings or patients) used from each database, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. However, these are established, publicly available retrospective databases commonly used for arrhythmia algorithm validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the AHA, MIT-BIH, CU, and NST databases was established by expert consensus during the creation of these databases. The specific number and qualifications of experts involved in the original annotation of these databases are not provided in this document but are well-documented within the respective database literature.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set beyond relying on the established ground truth of the referenced databases (AHA, MIT-BIH, CU, NST). These databases typically feature annotations derived from multiple expert reviews.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any effect size of human readers improving with AI vs without AI assistance. The study described focuses on standalone algorithm performance against established databases.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The ViSi Mobile Monitoring System's basic arrhythmia analysis was validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012. The QRS detection sensitivity of the ViSi System was reported as comparable to the predicate device.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus based on the established annotations within the AHA, MIT-BIH, CU, and NST databases.

8. Sample Size for the Training Set

The document does not provide specific details on the sample size used for the training set. It states that the basic arrhythmia analysis is based on the same technology as a previously cleared device (Monebo Technologies, Inc Arrhythmia library, K062282). This implies that a substantial training set was likely used during the development of the original algorithm, and possibly for adaptive training, but no specific numbers are given for the ViSi Mobile's training.

9. How the Ground Truth for the Training Set Was Established

Similarly, the document does not explicitly state how the ground truth for the training set was established. Given that the algorithm is based on a previously cleared library, it is highly probable that the training data and its ground truth were established through similar expert-annotated ECG datasets as those used for validation (e.g., subsets or similar types of data to the AHA, MIT-BIH databases).

Ask a specific question about this device

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

This document describes the ViSi Mobile Monitoring System, a vital signs monitor. However, the provided text does not contain the detailed study information required to fully answer all aspects of your request regarding acceptance criteria and performance study specifics. Specifically, it lacks quantitative performance data, sample sizes for test sets, details on expert panels, adjudication methods, or MRMC study results.

Based on the available information, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document mentions that acceptance criteria were met, but it does not provide specific numerical criteria or reported device performance metrics in a table format. It states: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide information on data provenance (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers, so such a study would likely not be applicable in this context. The modifications are related to posture tracking and associated alarms.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document implies that standalone performance testing of the algorithms was conducted, specifically:

• "SVT-000061 - Walking Algorithm Software Verification"
• "SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification"
• "TP-670 – Undesirable Posture Alarms Validation"
• "TP-671 Immobility Alarms Validation"
• "TP-672 Patient Fall Alarm Validation"
• ". TP-673 - Posture Definitions and Walking Validation"

These tests suggest evaluating the algorithms' accuracy in detecting posture, immobility, and falls. However, the specific metrics or acceptance criteria for these standalone tests are not provided in the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for the posture, immobility, and fall detection features. Given the nature of these features, ground truth would likely involve:

• Direct observation: Human observers physically verifying the patient's posture, movement, or fall event.
• Reference sensors/equipment: Other validated sensors (e.g., accelerometers, video analysis) used as a gold standard to establish true states.

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set.

9. How the ground truth for the training set was established

The document does not provide any information on how the ground truth for the training set was established.

Summary of available information regarding acceptance criteria and performance study:

The device under review is the ViSi Mobile Monitoring System, which added new posture alarm features (undesirable posture, immobility, patient fall) and the ability to display if a patient is walking.

Acceptance Criteria and Reported Performance:

• Acceptance Criteria for new features: The document generally states that "all acceptance criteria were met." However, the specific, quantitative acceptance criteria for each new feature (undesirable posture alarm, immobility alarm, patient fall alarm, walking detection) are not detailed.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for these features within this document. The statement is qualitative: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."

Study Information (Inferred/Partial):

• Type of Study: Non-clinical performance (verification and validation) testing.
• Test Set Sample Size: Not specified.
• Data Provenance: Not specified.
• Experts for Ground Truth: Not specified.
• Adjudication Method: Not specified.
• MRMC Study: Not applicable/not performed for this type of device modification.
• Standalone Performance: Yes, algorithm-only performance was evaluated through various software verification and validation tests related to walking, undesirable posture, immobility, and fall detection.
• Ground Truth Type: Not explicitly stated but likely involved direct observation or comparison with reference sensors for posture and movement.
• Training Set Sample Size: Not specified.
• Training Set Ground Truth Establishment: Not specified.

In conclusion, while the document confirms that verification and validation testing was conducted and acceptance criteria were met for the new posture features, it lacks the granular detail about the studies themselves, including specific performance metrics, sample sizes, and ground truth methodologies.

Ask a specific question about this device

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

This document is a 510(k) summary for the ViSi Mobile Monitoring System. It describes the device, its intended use, and provides a summary of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria in a quantitative manner (e.g., "sensitivity must be > X%"). Instead, it describes performance in terms of improvements or conformance to standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions the use of the "MIT and AHA databases." These are well-known, publicly available benchmark databases for ECG analysis. The specific number of records or patients from these databases used for testing is not explicitly stated in this summary.
• Data Provenance: The MIT and AHA databases are standard, established datasets. The country of origin and whether the data is retrospective or prospective is not specified in this document but is inherent to the nature of these established benchmark databases (typically retrospective and collected over time from various sources).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the MIT and AHA databases. For these widely recognized benchmark databases, the ground truth is typically meticulously annotated by multiple qualified experts over many years.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe the adjudication method used for establishing the ground truth of the MIT and AHA databases. This information is typically detailed in the documentation accompanying those specific databases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. The study described focuses on the standalone performance of the QRS detection algorithm against benchmark databases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The performance testing described, which involved the "new ECG beat-picker" against the MIT and AHA databases, is a standalone evaluation of the algorithm's performance without human-in-the-loop involvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the MIT and AHA databases, which were used to evaluate QRS detection, is based on expert consensus annotations of the ECG waveforms.

8. The sample size for the training set

The document does not provide information regarding the sample size of the training set used for the development or training of the new ECG beat-picker algorithm.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established.

Ask a specific question about this device

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to central station through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals

This K133586 submission is a special 510(k) for a modification to the ViSi Mobile Monitoring System. The modification is only to increase the time to alarm for critically low, low, and high heart rates. The device design, technology, materials, and processes remain unchanged. Therefore, a comprehensive study proving the device meets acceptance criteria related to its vital sign measurements is not included or required in this specific submission. The submission focuses on the safety and effectiveness of the alarm modification.

However, based on the information provided, we can infer some details that would typically be part of a full device submission, and we can specifically address the modification's impact based on the available text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to alarm timing, the acceptance criteria would primarily relate to the accuracy and timing of the alarms themselves. The document states "The modification is only to increase the time to alarm for critically low, low, and high heart rates". This implies the original device already had established performance for heart rate measurement.

Acceptance Criteria for Alarm Timing Modification:

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail a separate clinical or non-clinical test set for this specific modification. Since the change is only to alarm timing, a full-scale test set involving patient data for vital sign accuracy is not described. It is more likely that:

• Bench testing: The modified alarm logic would have been tested extensively in a lab setting using simulated heart rate data to verify the new alarm delays.
• Safety assessment: A risk analysis would have been performed to ensure the increased alarm delay does not pose an undue risk to patients.

Therefore, specific sample sizes for a "test set" in the context of vital sign accuracy or a large clinical study are not mentioned for this specific submission. The data provenance for such bench testing would originate from the manufacturer's internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this modification as it pertains to alarm timing logic, not the accuracy of a diagnostic output where expert consensus would be needed. The "ground truth" for alarm timing would be the specified delay parameter implemented in the software.

4. Adjudication Method for the Test Set

Not applicable for this modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This device is a vital signs monitor, not an interpretive AI system that human readers would interact with in a diagnostic context. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in the sense that the alarm logic itself functions "standalone" as part of the device's software. The performance of the alarm delay would be tested independently of human intervention during the verification and validation process to ensure it triggers at the correct (newly modified) time. However, this is not an "AI algorithm" in the common sense of the term.

7. The Type of Ground Truth Used

For the specific modification of alarm timing, the ground truth would be:

• Defined Technical Specifications: The new, increased alarm delay times specified by the manufacturer.
• Validated System Behavior: Demonstrating that the device's software accurately implements these new delay times.

For the original vital sign measurements (HR, SpO2, NIBP, etc.) (from the predicate device's submission), the ground truth would typically be established using:

• Reference Devices: Comparing measurements from the ViSi Mobile Monitoring System to simultaneously acquired measurements from highly accurate,
  calibrated reference devices (e.g., an invasive arterial line for NIBP, a co-oximeter for SpO2, a reference ECG for HR).
• Physiological Stimulators: Using simulators to generate known vital signs for testing.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense. The alarm logic is rule-based and modified through program changes, not through machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device and modification.

Ask a specific question about this device

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult (18 years or older) patients. It is indicated for ECG (3 or 5 leadwire), respiration rate, non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ViSi Mobile Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "clinical performance validation," but provides no numbers.

The data provenance is not specified regarding country of origin. The studies were clinical performance validations, which implies prospective data collection, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish ground truth for the test set. Instead, it states that the ViSi's MAP measurement was "validated by comparison to an intra-arterial reference." This indicates that invasive, direct arterial blood pressure measurements were used as the gold standard for comparison.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the ground truth was established by direct intra-arterial measurements rather than expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a vital signs monitor and does not involve "human readers" interpreting images or data that AI would assist with in the typical sense of MRMC studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies conducted were standalone performance evaluations of the device's ability to accurately measure blood pressure. The performance criteria (mean error and standard deviation) are algorithm-only metrics comparing the device's output to a reference standard.

7. The Type of Ground Truth Used

The ground truth used for both intermittent NIBP MAP and cNIBP was intra-arterial reference measurements. This is considered a gold standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. This is because the device's performance validation is based on clinical testing against a reference standard, not a machine learning model that requires a distinct training and testing set. The "auto-calibration to NIBP measurements" mentioned for cNIBP implies a form of continuous adaptation, but doesn't define a traditional "training set" in the context of supervised learning.

9. How the Ground Truth for the Training Set Was Established

Since a traditional "training set" in the machine learning sense is not applicable or explicitly mentioned for this device's validation, the method for establishing its ground truth is also not provided. Any internal calibration or learning processes would likely use intra-arterial or NIBP reference measurements as their "truth."

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The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to a central station through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals.

The provided document (510(k) Summary for the ViSi Mobile Monitoring System) does not contain detailed information about specific acceptance criteria, a comprehensive study outline proving these criteria, or specific performance metrics with sample sizes, ground truth establishment, or expert qualifications for the device's various parameters.

The document primarily focuses on describing the device, its indications for use, and a general statement about its safety and effectiveness based on compliance with recognized standards and similarities to predicate devices. It also mentions "verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection." However, it does not provide the specifics of these verification and validation activities in terms of acceptance criteria and study details.

Therefore, I cannot populate the requested table and answer the specific questions about the study design, sample sizes, ground truth, and expert involvement based solely on the provided text.

The information that is available from the document is:

• Device Name: ViSi Mobile Monitoring System
• Intended Use: Single or multi-parameter vital signs monitoring of adult patients in hospital-based facilities (general medical-surgical floors, intermediate care floors, and emergency departments) for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP).
• General Claim: "The ViSi System has been tested and complies with recognized performance, safety, and electromagnetic compatibility standards for medical devices. The verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent."

To answer your request, a more detailed study report or clinical trial summary would be necessary, which is typically a separate document from the 510(k) summary itself.

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The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals

The provided text describes the Sotera Wireless ViSi Mobile Monitoring System and references a clinical study for its NIBP measurement method. However, it does not provide explicit acceptance criteria with specific numerical performance targets or detailed results of a study that directly proves the device meets these criteria in a tabulated format.

The text states:
"The validity of this method [NIBP measurement on inflation] was confirmed in an ISO 81060-2 compliant clinical study demonstrating that this method of blood pressure meets the requirements of the standard in terms of accuracy and variability."

Based on this, here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific numerical values for accuracy (e.g., mean difference and standard deviation) and variability (e.g., standard deviation of differences) as defined by ISO 81060-2 are not provided in the document.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not specified for the NIBP clinical study.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, clinical studies for medical devices are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• This question is not applicable in the context of device performance testing against a standard like ISO 81060-2 for NIBP. The "ground truth" for blood pressure measurement in such studies typically refers to a reference method (e.g., intra-arterial catheter) or a highly accurate sphygmomanometer used by trained clinicians, not "experts" establishing a diagnosis. The document does not specify the ground truth method.

4. Adjudication Method for the Test Set

• Not applicable in this context. Testing against a standard for a physiological measurement device usually involves comparing the device's readings to a reference method, not an adjudication process by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done, or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The ViSi Mobile Monitoring System is a vital signs monitor, not an image interpretation device.

6. Standalone Performance Study

• Yes, a standalone study was performed. The NIBP clinical study is a standalone performance study, as it evaluates the device's ability to measure blood pressure against a standard, without human interpretation of the output.

7. Type of Ground Truth Used

• The document states the NIBP method "meets the requirements of the standard in terms of accuracy and variability." While not explicitly stated, the ground truth for an ISO 81060-2 compliant clinical study for NIBP typically involves:
  • Simultaneous measurements: The device under test and a validated reference method (e.g., intra-arterial measurement or a highly accurate auscultatory method performed by trained operators) are used simultaneously.

8. Sample Size for the Training Set

• Not applicable as this document describes performance testing of a medical device against a standard, not the development of an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable (see point 8).

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